MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT¿; STENT, CAROTID

Model Number H965SCH647080

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that inadvertent stent deployment occurred.While opening the packaging of a 8.0-29mm carotid wallstent¿, it was found that the tip of the stent came out.Therefore the physician released the stent.This occurred outside of the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition after the procedure was stable.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: the carotid delivery device was returned for analysis without the stent.A visual and tactile examination of the device identified no damage or any issues with the catheter.Examination of the device identified no damage or any issues with the stent cups, stent holder or tip.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that inadvertent stent deployment occurred.While opening the packaging of a 8.0-29mm carotid wallstent¿, it was found that the tip of the stent came out.Therefore the physician released the stent.This occurred outside of the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition after the procedure was stable.

• Brand Name: CAROTID WALLSTENT¿
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7495660
• MDR Text Key: 107636588
• Report Number: 2134265-2018-03898
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2020
• Device Model Number: H965SCH647080
• Device Catalogue Number: SCH-64708
• Device Lot Number: 0020777270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Date Manufacturer Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR